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Study of Treatment Used for Migraine Headaches (MK-0974-076) (MASTER)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01421277
First received: July 28, 2011
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

This study will describe the reasons for triptan utilization patterns (continuation and discontinuation) in triptan-naïve participants and assess the stability of treatment utilization patterns over time according to standard medical guidelines or clinical practice standards of the investigating physician.


Condition Intervention
Migraine
Drug: Statin Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Migraine Attack Study of Treatment, Efficacy and Resource Use (MASTER) - McKesson Substudy (MK-0974-076)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Using a Triptan for Migraine Attacks [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    Participants reported information online. For this measure, the number of participants who used at least one dose of any newly prescribed triptan for the first time in response to a migraine attack were counted.

  • Number of Participants Continuing Triptan Therapy [ Time Frame: Up to 3 monoths ] [ Designated as safety issue: No ]
    Participants reported information online. For this measure, the number of participants who continued to use a triptan after the first migraine attack were counted; switching from one triptan to another was considered continued use.

  • Main Reason for Stopping Triptan Use [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]

Enrollment: 216
Study Start Date: May 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants Enrolled in Protocol Version (V)1.1
Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
Drug: Statin Therapy
Investigator's choice of any statin.
Participants Enrolled in Protocol V2
Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
Drug: Statin Therapy
Investigator's choice of any statin.

Detailed Description:

After study start, the Protocol was amended to clarifiy that the first triptan prescription must have been received by the participant within a time window of 3 months (± 2 weeks) prior to the participant being identified by the Investigator, and could be enrolled into the study within 6 months of taking the prescribed triptan medication for the first time and that use of a sample triptan would not disqualify a participant as long as the sample was of the same triptan that was eventually prescribed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants with physician-diagnosed migraine (with or without aura) who have had at least two, but not more than 8 moderate to severe migraines during the 30 days prior to screening. Participants must have received a triptan prescription 3 months (± 2 weeks) prior to being identified by the physician, must have been triptan-naïve prior to that initial prescription, and must have taken triptan medication at least once within 6 months prior to the date of informed consent for screening.

Criteria

Inclusion criteria:

  • At least 18 years of age in the United States at the time of consent
  • Physician-diagnosed migraine with or without aura
  • At least two and up to a maximum of 8 moderate to severe migraine attacks during the 30 days prior to screening
  • Initial triptan prescription 3 months (± 2 weeks) prior to being identified as eligible for this study, and triptan-naïve before that initial prescription
  • Used triptan medication at least once within 6 months prior to the date of informed consent for screening
  • Internet access and able to complete online surveys via electronic data entry

Exclusion criteria:

  • Treated with triptans prior to this study
  • In active litigation and compensation issues including disability dispute cases with a Government agency
  • Participation in a clinical trial within the last 90 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01421277     History of Changes
Other Study ID Numbers: 0974-076
Study First Received: July 28, 2011
Results First Received: September 8, 2014
Last Updated: October 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases

ClinicalTrials.gov processed this record on November 27, 2014